Magnify: The Art and Science of Diagnostic Medicine

ARUP’s Message to Clients Amid a Shifting Regulatory Environment: We’ll Continue To Support Our Clients So They Can Support Their Patients

Drawing on more than a decade of experience and engagement in efforts at the federal level, ARUP Laboratories is prepared to support its clients’ needs while also educating and advocating on behalf of all clinical labs as they work to understand the new regulatory environment and its effect on clinical labs.

Read more and watch ARUP leaders discuss the new FDA rule and ARUP’s response in the latest edition of Magnify here.

ARUP LabMind Podcast

Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs, joins Brian Jackson, MD, MS, medical director of Business Development, to answer listeners’ questions on the FDA’s final rule to regulate laboratory-developed tests (LTDs), discuss whether the rule will hold up in court, and explain which tests are subject to which requirements.

Listen here.

ARUP Hosts Informational Webinar on the FDA's Final Rule on LDTs

Summary: The FDA’s final published rule on LDTs will result in new oversight that will dramatically shift how clinical laboratories can develop and offer LDTs going forward. In this recorded webinar, ARUP Chief Medical Officer and Senior Director of Governmental Affairs Jonathan Genzen, MD, PhD, MBA, and Chief Compliance Officer Jonathan Carr, JD, provide an overview of the requirements included in the final rule and how these requirements differ across certain settings and types of testing. The webinar concludes with a Q&A session in which they share their perspectives on questions submitted by registered attendees.

• Watch here.
• Slide deck from webinar
• Requirements matrix

Additional Webinars

Association for Diagnostics and Laboratory Medicine (ADLM) Webinars Featuring Jonathan Genzen, MD, PhD, MBA, ARUP Chief Medical Officer and Senior Director of Governmental Affairs

• The FDA’s Rule on Lab-Developed Tests—What It Means for You
• Complying with the FDA’s rule on LDTs: What You Need to Do and When